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Lipomas Treated With Subcutaneous Injections of Cooled or Warmed Sodium Chloride

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllWest Virginia University
NCT06820164 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Lipomas are benign tumors composed of mature adipose tissue. While harmless, these are the most common type of soft tissue growths with some patients developing numerous lipomas. Patients often seek removal for cosmesis, or symptoms caused by location and/or compression of surrounding structures. This exploratory study aims to evaluate the effectiveness of subcutaneous injections of cooled normal saline as a treatment option for lipomas. The study will assess whether this technique could serve as a viable alternative to existing treatment options, especially compared to topically applied fat-freezing devices. The Investigators propose that this method may offer a more comfortable nonsurgical option for targeted fat reduction, as the cold temperatures are applied directly to the lipomas. Amendment to Protocol Feb 2026- Including and additional ARM of the study to evaluate the effectivene

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📋 Eligibility rules (as published)
Inclusion Criteria: * At least one clinically diagnosed subcutaneous lipoma Exclusion Criteria: * Unable to give informed consent * Participant has a lipoma on the face * Lipomas located subfascial or within deep tissue (e.g., intramuscular lipomas) * Lipomas larger than 10 cm in diameter (fat deposits exceeding 500 mL in volume) * Rapidly growing lipomas * Lipomas exhibiting abnormal ultrasound findings (e.g., complex hyperechoic patterns, internal heterogeneity, or multilobulated appearance) * Pregnant women
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What it tests

  • Cooled Sodium Chloride Injection
  • Warmed Sodium Chloride Injection
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Where

1 site
West Virginia University
Morgantown, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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